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The pre-clinical evaluation team at VDEC provides a safe and controlled environment to test new vaccines and therapeutics before they progress to clinical trials
Guidance for healthcare professionals on risk minimisation options for medicines.
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
This publication supports local authority health and wellbeing boards to develop and update pharmaceutical needs assessments (PNAs).
Supplementary information for international regulators on packaging changes and the export of UK medicines.
The MHRA's initial plans on an Early Access service, which will be developed further throughout 2025.
How manufacturers can comply with the regulations when providing instructions for using medical devices in an electronic form.
Instructions for integrating with the new production MORE platform API.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Outlines the aim, scope and definitions of the medical technology innovation classification framework.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Scientific advice queries on nanomedicines have increased in recent years, particularly on lipid nanoparticles.
Detailing the information you need to provide the MHRA when you notify us of your clinical investigation plans.
VDEC’s Discovery and surveillance capabilities provide unique services across a spectrum of molecular immunology platforms.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) laboratory inspection reports.
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Guidance for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
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